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NCT05445024
Combination of Nalbuphine and Dexmedetomidine Versus Sufentanil and Dexmedetomidine on Patients
NA trial testing nalbuphine group in Laparoscopic in 300 participants. Status unknown.
30 November 2023
Quick facts
| Lead sponsor | Qianfoshan Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 300 |
| Start date | 1 January 2023 |
| Primary completion | 30 November 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- nalbuphine group
- sufentanil group
Conditions studied
- Laparoscopic — all drugs for Laparoscopic →
- Gastrointestinal Surgery — all drugs for Gastrointestinal Surgery →
Sponsor
Qianfoshan Hospital
Who can join
Adults 18 to 75, any sex, with Laparoscopic or Gastrointestinal Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Surgical pain refers to pain that occurs immediately after surgery, including physical pain and visceral pain. Thus, it severely challenges the proper use of analgesics for patients undergoing laparoscope gastrointestinal surgery to clinicians. Nalbuphine is a mixed agonist-antagonist opioid. The investigators hypothesized that the clinical effect of nalbuphine in combination with dexmedetomidine might be different from that of sufentanil in combination with dexmedetomidine. So, the investigators performed a nalbuphine and dexmedetomidine dose finding study, for the patient controlled anaesthesia (PCA) after the laparoscopic gastrointestinal surgery, to establish their 95% effective dose (ED95). The investigators then compared the clinical effect and adverse events of the newly established dosing regimen of nalbuphine combined with dexmedetomidine, to the equivalent dosing of sufentanil combined with dexmedetomidine, in the same patient population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05445024
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05445024 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Qianfoshan Hospital
- Last refreshed: 4 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05445024.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing